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| Primary information |
|---|
| ID | 10710 |
| Therapeutic ID | Th1163 |
| Protein Name | Ancestim |
| Sequence | >Th1163_Ancestim
MEGICRNRVTNNVKDVTKLVANLPKDYMITLKYVPGMDVLPSHCWISEMVVQLSDSLTDLLDKFSNISEGLSNYSIIDKLVNIVDDLVECVKENSSKDLKKSFKSPEPRLFTPEEFFRIFNRSIDAFKDFVVASETSDCVVSSTLSPEKDSRVSVTKPFMLPPVA
|
| Molecular Weight | 18540 |
| Chemical Formula | C1662H2650N422O512S18 |
| Isoelectric Point | 5.86 |
| Hydrophobicity | NA |
| Melting point | 230ºC |
| Half-life | 2-5 hours |
| Description | Ancestim is a recombinant methionyl human stem cell factor, branded by Amgen as StemGen. It was developed by Amgen and sold to Biovitrium, now Swedish Orphan Biovitrum, in December, 2008. It is a 166 amino acid protein produced by E. coli bacteria into which a gene has been inserted for soluble human stem cell factor. It has a monomeric molecular weight of approximately 18,500 daltons and normally exists as a noncovalently associated dimer. The protein has an amino acid sequence that is identical to the natural sequence predicted from human DNA sequence analysis, except for the addition of an N-terminal methionine retained after expression in E. coli. Because Ancestim is produced in E. coli, it is nonglycosylated. Ancestim is supplied as a sterile, white, preservative-free, lyophilised powder for reconstitution and administration as a subcutaneous (SC) injection and is indicated for use in combination with filgrastim for mobilizing peripheral hematopoietic stem cells for later transplanation in certain cancer patients |
| Indication/Disease | Indicated for use in combination with filgrastim for mobilizing peripheral hematopoietic stem cells for later transplanation in certain cancer patients |
| Pharmacodynamics | NA |
| Mechanism of Action | Recombinant human stem cell factor |
| Toxicity | Ancestim was not genotoxic for gene mutation or chromosomal damage and it did not have any effect in fertility.[L1089] |
| Metabolism | Administration of ancestim in preclinical trials have proven that from the excreted dose all of it is formed by degraded ancestim into lower molecular weigth products.[L1089] |
| Absorption | The pharmacokinetics of ancestim has a dose-linear profile. After subcutaneous administration, ancestim has an absorption half-life of 35-41 hours following a mean lag of 2 hours. When a dose of 5-25 mcg/kg is administered, the peak concentration of 3.6-13.7 ng/ml is reached after 15-24 hours. In preclinical studies, the bioavailability of ancestim was reported to be greater than 60%. After multiple dosing, the steady state was reached after 4-5 days from the beginning of the treatment.[L1089] |
| Preclinical reports demonstrate that after intravenous administration of ancestim, the distribution profile is primarily in plasma and kidneys with a subsequent and rapid loss from all tissues.[L1089] |
| Clearance | The apparent clearance reported for ancestim is approximately 35-40 ml/h/kg.[L1089] |
| Categories | NA |
| Patents Number | NA |
| Date of Issue | NA |
| Date of Expiry | NA |
| Drug Interaction | NA |
| Target | Mast/stem cell growth factor receptor Kit |
| Brand Name | Stemgen |
| Company | Biovitrum Ab (publ) |
| Brand Description | Biovitrum Ab (publ) |
| Prescribed For | indicated for use in combination with NEUPOGEN® (filgrastim) in the setting of autologous peripheral blood progenitor cell (PBPC) transplantation for patients at risk of poor PBPC mobilisation to increase the number of PBPC collected in the apheresis harvest, thereby increasing the proportion of patients reaching a PBPC target for transplantation. |
| Chemical Name | NA |
| Formulation | Reconstitute with 1.2 mL sterlie water for injection to yield a concentration of 1.5 mg/mL with a withdrawable volume of 1 mL. Compatibility with saline or other diluents is unknown. During reconstitution, the vial contents may be gently swirled to avoid foaming during dissolution. Avoid excess or vigorous agitation |
| Physical Appearance | NA |
| Route of Administration | Subcutaneous |
| Recommended Dosage | 20 mcg/kg/day SC |
| Contraindication | It is contraindicated in patients with known hypersensitivity to E coli-derived proteins, ancestim or any component of the product; increased risk of systemic allergic reactions (greater incidence and severity) when STEMGEN® was administered by the IV route |
| Side Effects | Injection site reactions (92%); Paresthesia (29%); Respiratory symptoms (28%); Distant skin reactions (21%);Nausea (16%); Headache (13%); Dizziness (12%); Tachycardia (8%) |
| Useful Link 1 | Link |
| Useful Link 2 | NA |
| Remarks | NA |